Trial Outcomes & Findings for Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure (NCT NCT01089062)
NCT ID: NCT01089062
Last Updated: 2014-01-09
Results Overview
AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg\*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
2 hours from time of first dose
Results posted on
2014-01-09
Participant Flow
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.
Participant milestones
| Measure |
Treatment A, Then B, Then C
The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and Intravenous (IV) Dihydroergotamine (DHE) for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4.
|
Treatment A, Then C, Then B
The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4.
|
Treatment B, Then A, Then C
The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4.
|
Treatment B, Then C, Then A
The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.
|
Treatment C, Then A, Then B
The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4.
|
Treatment C, Then B, Then A
The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4.
|
|---|---|---|---|---|---|---|
|
Visit 2 (Randomization)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Visit 2 (Randomization)
COMPLETED
|
3
|
3
|
3
|
4
|
3
|
3
|
|
Visit 2 (Randomization)
NOT COMPLETED
|
1
|
1
|
1
|
0
|
1
|
1
|
|
Visit 3
STARTED
|
3
|
3
|
3
|
4
|
3
|
3
|
|
Visit 3
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Visit 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Visit 4
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Visit 4
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Visit 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Follow-up Visit (Final Visit)
STARTED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Follow-up Visit (Final Visit)
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
3
|
|
Follow-up Visit (Final Visit)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
Baseline characteristics by cohort
| Measure |
Treatment A, Then B, Then C
n=4 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
Treatment A, Then C, Then B
n=4 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
Treatment B, Then A, Then C
n=4 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
Treatment B, Then C, Then A
n=4 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
Treatment C, Then A, Then B
n=4 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
Treatment C, Then B, Then A
n=4 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
23.4 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
28.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
26.5 years
STANDARD_DEVIATION 7.4 • n=21 Participants
|
24.8 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
26.6 years
STANDARD_DEVIATION 6.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 2 hours from time of first dosePopulation: Patients with available data at the required time point were included in the analysis population.
AUC(0-2hrs) (Area Under the Curve, time 0-2 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg\*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.
Outcome measures
| Measure |
Treatment A
n=18 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=18 Participants
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=18 Participants
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
AUC(0-2hrs) of Pulmonary Arterial Systolic Pressure (PASP) Over Time Post 1st Dose
|
2794.93 mmHg*min
Standard Deviation 476.66
|
2580.06 mmHg*min
Standard Deviation 389.06
|
2497.71 mmHg*min
Standard Deviation 384.29
|
SECONDARY outcome
Timeframe: baseline and 2 hours from the time of first dosePopulation: Patients with available data at the required time point were included in the analysis population.
Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=24 Participants
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=24 Participants
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
Percent of Subjects With an Increase in PASP Greater Than 10mmHg From Baseline to 2 Hours From the First Dose
|
4.2 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 2 hours from the time of first dosePopulation: Patients with available data at the required time point were included in the analysis population.
Pulmonary artery systolic pressure (PASP) is the highest pressure exerted on the walls of the pulmonary artery.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=24 Participants
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=24 Participants
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose
Max Change from Baseline over 2 hrs from 1st dose
|
7.8 mmHg
Standard Deviation 2.4
|
6.1 mmHg
Standard Deviation 2.8
|
4.0 mmHg
Standard Deviation 1.7
|
|
Maximum Change in PASP From Baseline to the Two Hour Period Following the First Dose
Baseline
|
22.8 mmHg
Standard Deviation 4.4
|
19.2 mmHg
Standard Deviation 4.6
|
21.2 mmHg
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 4 hours from the time of first dosePopulation: Patients with available data at the required time point were included in the analysis population.
AUC(0-4hrs) (Area Under the Curve, time 0-4 hours post-1st dose) in PASP millimeters of mercury times minutes (mmHg\*min). PASP is the highest pressure exerted on the walls of the pulmonary artery.
Outcome measures
| Measure |
Treatment A
n=24 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=24 Participants
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=24 Participants
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
AUC(0-4hrs) of Pulmonary Arterial Systolic Pressure (PASP) From the Start of the First Dose to Two Hours After the Second Dose
|
5700.11 mmHg*min
Standard Deviation 1016.86
|
5336.38 mmHg*min
Standard Deviation 823.51
|
4907.03 mmHg*min
Standard Deviation 773.11
|
SECONDARY outcome
Timeframe: baseline, 10 minutes post 1st dose, 10 minutes post 2nd dosePopulation: Patients with available data at the required time point were included in the analysis population.
Systolic and diastolic blood pressure measure the lowest and highest pressures against the walls of the arteries. Changes were calculated from 30 minutes pre dose (baseline) to 10 minutes post first and second dose. A positive change from baseline indicates an increase in blood pressure and a negative change indicates a decrease in blood pressure.
Outcome measures
| Measure |
Treatment A
n=20 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=20 Participants
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=20 Participants
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Baseline Systolic
|
112.5 mmHg
Standard Deviation 11.3
|
113.3 mmHg
Standard Deviation 15.3
|
113.2 mmHg
Standard Deviation 12.3
|
|
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Change at 10 min in Systolic after 1st dose
|
10.4 mmHg
Standard Deviation 10.0
|
4.7 mmHg
Standard Deviation 8.5
|
0.4 mmHg
Standard Deviation 7.9
|
|
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Change at 10 min in Systolic after 2nd dose
|
0.2 mmHg
Standard Deviation 7.8
|
1.2 mmHg
Standard Deviation 9.9
|
-0.5 mmHg
Standard Deviation 5.2
|
|
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Baseline Diastolic
|
65.8 mmHg
Standard Deviation 7.3
|
67.2 mmHg
Standard Deviation 9.1
|
64.4 mmHg
Standard Deviation 6.7
|
|
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Change at 10 min in Diastolic after 1st dose
|
7.0 mmHg
Standard Deviation 7.2
|
2.0 mmHg
Standard Deviation 8.0
|
1.1 mmHg
Standard Deviation 5.1
|
|
Change in Blood Pressure From Baseline After the Two 2-hour Post Dosing Periods
Change at 10 min in Diastolic after 2nd dose
|
-1.5 mmHg
Standard Deviation 11.2
|
-2.0 mmHg
Standard Deviation 9.4
|
0.1 mmHg
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: baseline, 14 minutes from time of 1st dose, 14 minutes from time of 2nd dosePopulation: Patients with available data at the required time point were included in the analysis population.
The corrected QT interval (QTc) is a measurement of the electrical impulses through the largest part of the heart muscle. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Outcome measures
| Measure |
Treatment A
n=20 Participants
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=20 Participants
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=20 Participants
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose
Baseline
|
403.9 milliseconds
Standard Deviation 15.8
|
402.3 milliseconds
Standard Deviation 19.0
|
399.9 milliseconds
Standard Deviation 16.4
|
|
Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose
Change from baseline at 14 mins post 1st dose
|
-5.8 milliseconds
Standard Deviation 12.2
|
-0.8 milliseconds
Standard Deviation 5.6
|
2.4 milliseconds
Standard Deviation 10.8
|
|
Change From Baseline in QTc Interval at 14 Minutes After the 1st and 2nd Dose
Change from baseline at 14 mins post 2nd dose
|
1.5 milliseconds
Standard Deviation 10.7
|
-0.8 milliseconds
Standard Deviation 13.4
|
4.1 milliseconds
Standard Deviation 9.6
|
Adverse Events
Treatment A
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A
n=20 participants at risk
Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
|
Treatment B
n=20 participants at risk
Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
|
Treatment C
n=20 participants at risk
Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
30.0%
6/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
25.0%
5/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
10.0%
2/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Burning sensation
|
20.0%
4/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Paraesthesia
|
15.0%
3/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Head discomfort
|
10.0%
2/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Somnolence
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Nervous system disorders
Sensory Disturbance
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
10/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
2/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Gastrointestinal disorders
Stomach discomfort
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Feeling hot
|
40.0%
8/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Chest discomfort
|
10.0%
2/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Asthenia
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Fatigue
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Infusion site pain
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
General disorders
Sensation of pressure
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Social circumstances
Pharmaceutical product complaint
|
20.0%
4/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
10.0%
2/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Vascular disorders
Flushing
|
10.0%
2/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Vascular disorders
Hot flush
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Eye disorders
Vision blurred
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
|
Investigations
Heart rate increased
|
5.0%
1/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
0.00%
0/20
All subjects who were randomized and received at least one dose of study drug were included in the adverse event analysis. Adverse events are presented by treatment arm, not by individual treatment (intervention) received.
|
Additional Information
VP, Scientific Affairs
MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
Phone: 650-386-3100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER